Using Combine Walking and Elastic Band to Decrease Fatigue
Primary Purpose
Cancer Related Fatigue
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Related Fatigue
Eligibility Criteria
Inclusion Criteria: age 20 years old; diagnosis of cancer; can continuous wearing bracelet for 14 days or more Exclusion Criteria: Unclear and unable to answer the questionnaire; Not able to walk; platelet <50,000/mm3; ANC 500/cumm
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
exercise
usual care
Arm Description
combine walking and elastic band exercise
as usual care
Outcomes
Primary Outcome Measures
cancer fatigue--BFI
severity of fatigue level; measurement tool: Brief Fatigue Index
cancer fatigue--BFI
severity of fatigue level; measurement tool: Brief Fatigue Index
Secondary Outcome Measures
Physical Activity assessment--IPAQ
International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high.
Physical Activity assessment--IPAQ
International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high.
Chinese version of the Edmonton Symptom Assessment System,C-ESAS
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
Chinese version of the Edmonton Symptom Assessment System,C-ESAS
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
Sleep quality--PSQI
Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality.
Sleep quality--PSQI
Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality.
Steps count
more steps means good for ability
Steps count
more steps means good for ability
walking distance
Longer distances mean better movement
walking distance
Longer distances mean better movement
strength ability
Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
strength ability
Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
Smart bracelet_Heart rate variability (HRV)
HRV is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. A normal, healthy heart does not tick evenly like a metronome, but instead, when looking at the milliseconds between heartbeats, there is constant variation.
Full Information
NCT ID
NCT05696275
First Posted
November 16, 2022
Last Updated
January 13, 2023
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05696275
Brief Title
Using Combine Walking and Elastic Band to Decrease Fatigue
Official Title
Exercise-aided Caring System With Dual-mode Assessment Method Using ePRO and Wearables for Cancer-related Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 16, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is expected to propose an industry-university cooperation research case for the next two years. When cancer patients use ePRO to record subjective fatigue, and smart watches with 4G communication record objective fatigue, they will be given according to the patient's current degree of mild, moderate and severe fatigue. Suffer from 'exercise or activity' advice and lead the implementation of appropriate exercise advice. This study is expected to design aerobic + anaerobic exercise suitable for mild or moderate patients, and use the sensor of the smart watch to monitor the effect of exercise and fatigue. To sum up, the first-year plan is expected to use the established ePRO electronic records, combined with the LINE communication system, to integrate into a "cancer-related fatigue electronic registration and care system"; the second-year plan will integrate objective fatigue classifiers, Establish the exercise care option in the fatigue care system, and use the smart watch to establish a technology record function of the exercise process to help track the fatigue level of cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Related Fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise
Arm Type
Experimental
Arm Description
combine walking and elastic band exercise
Arm Title
usual care
Arm Type
No Intervention
Arm Description
as usual care
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
20-30 minutes of walking and elastic band exercise per day
Primary Outcome Measure Information:
Title
cancer fatigue--BFI
Description
severity of fatigue level; measurement tool: Brief Fatigue Index
Time Frame
Change from Baseline post exercise 5 min
Title
cancer fatigue--BFI
Description
severity of fatigue level; measurement tool: Brief Fatigue Index
Time Frame
Change from Baseline at 1 month.
Secondary Outcome Measure Information:
Title
Physical Activity assessment--IPAQ
Description
International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high.
Time Frame
Change from Baseline post exercise 5 min
Title
Physical Activity assessment--IPAQ
Description
International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high.
Time Frame
Change from Baseline at 1 month.
Title
Chinese version of the Edmonton Symptom Assessment System,C-ESAS
Description
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
Time Frame
Change from Baseline post exercise 5 min
Title
Chinese version of the Edmonton Symptom Assessment System,C-ESAS
Description
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
Time Frame
Change from Baseline at 1 month.
Title
Sleep quality--PSQI
Description
Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality.
Time Frame
Change from Baseline post exercise 5 min
Title
Sleep quality--PSQI
Description
Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality.
Time Frame
Change from Baseline at 1 month.
Title
Steps count
Description
more steps means good for ability
Time Frame
Change from Baseline post exercise 5 min
Title
Steps count
Description
more steps means good for ability
Time Frame
Change from Baseline at 1 month.
Title
walking distance
Description
Longer distances mean better movement
Time Frame
Change from Baseline post exercise 5 min
Title
walking distance
Description
Longer distances mean better movement
Time Frame
Change from Baseline at 1 month.
Title
strength ability
Description
Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
Time Frame
Change from Baseline post exercise 5 min
Title
strength ability
Description
Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
Time Frame
Change from Baseline at 1 month.
Title
Smart bracelet_Heart rate variability (HRV)
Description
HRV is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. A normal, healthy heart does not tick evenly like a metronome, but instead, when looking at the milliseconds between heartbeats, there is constant variation.
Time Frame
Continue wear bracelet five days to record HRV data.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 20 years old;
diagnosis of cancer;
can continuous wearing bracelet for 14 days or more
Exclusion Criteria:
Unclear and unable to answer the questionnaire;
Not able to walk;
platelet <50,000/mm3;
ANC 500/cumm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsai-Wei Huang, PhD
Phone
+886-2-27361661
Ext
6350
Email
tsaiwei@tmu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Using Combine Walking and Elastic Band to Decrease Fatigue
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